FDA 510(k) Application Details - K081052

Device Classification Name	Catheter, Flow Directed   More FDA Info for this Device
510(K) Number	K081052
Device Name	Catheter, Flow Directed
Applicant	Oscor Inc. 3816 DE SOTO BLVD. PALM HARBOR, FL 34683 US Other 510(k) Applications for this Company
Contact	MILA DOSKOCIL Other 510(k) Applications for this Contact
Regulation Number	870.1240   More FDA Info for this Regulation Number
Classification Product Code	DYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2008
Decision Date	06/18/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review